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Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers

Information source: University of South Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Fatigue; Hypothyroidism

Intervention: physiologic testing (Other); fatigue assessment and management (Procedure); management of therapy complications (Procedure)

Phase: N/A

Status: Completed

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Nagi B. Kumar, PhD RD FADA, Study Chair, Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Summary

RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably. PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo chemotherapy compared to how often it happens in healthy volunteers.

Clinical Details

Official title: Thyroid Function & Breast Cancer: A Pilot Study to Estimate the Prevalence of Thyroid Dysfunction in Women Diagnosed With Breast Cancer and the Magnitude of Change in Thyroid Function Post-Chemotherapy

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome:

Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers

Compare change in thyroid function from baseline to 24 months after enrollment

Secondary outcome: Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment

Detailed description: OBJECTIVES: Primary

- Compare the proportion of hypothyroidism in women with newly diagnosed stage I-IIIB

breast cancer (prior to chemotherapy) vs in cancer-free, age-matched healthy volunteers.

- Compare the magnitude of change in thyroid function in these patients from baseline to

24 months vs in cancer-free, age-matched healthy volunteers. Secondary

- Correlate variation in thyroid function with fatigue symptom scores.

- Correlate variation in thyroid function with anthropometric measurements.

OUTLINE: This is a pilot, multicenter study. Patients and age-matched healthy volunteers undergo blood collection at baseline and at 12 and 24 months after enrollment. They also undergo anthropometric measurements and complete the Fatigue Symptom Inventory at baseline and at 12 and 24 months after enrollment. PROJECTED ACCRUAL: A total of 270 patients and 280 healthy volunteers will be accrued for this study.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

CASE SELECTION:

- CASE INCLUSION CRITERIA:

- Women between the ages of 25 and 75

- Diagnosed with primary and operable Stage I - IIIB breast cancer

- Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a

taxane (taxane may be given with AC or follow AC)

- No chemotherapy prior to baseline sample collection

- No prior history of other cancers (except non-melanoma skin cancer)

- Preoperative radiation therapy is permitted

- No diagnosis of hypothyroidism or hyperthyroidism.

- CASE EXCLUSION CRITERIA:

- Stage IV breast cancer

- Scheduled to receive neoadjuvant hormonal therapy (patients who will receive adjuvant

hormonal therapy may participate)

- Received adjuvant hormonal therapy or chemotherapy prior to sample collection

- On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.

- Patients receiving monoclonal antibodies or other biologic therapy may not

participate

- Patients scheduled to receive Herceptin may not participate

- Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for

hypothyroidism are not eligible)

- Women with a baseline TSH of 10 or higher will not continue on study

- Women who are pregnant or lactating are not eligible. (Women of childbearing

potential who are planning to become pregnant within the next 24 months should not enroll in this study) CONTROL SELECTION:

- CONTROL INCLUSION CRITERIA:

- Cannot be a blood relative of the case. They can be friends, neighbors, women from

social activities, local business, doctors' offices, etc.

- Must live near or in the town of the case

- Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)

- No prior history of cancer (except non-melanoma skin cancer)

- Women ages 40 and older should have had a mammogram within 2 years of study entry,

showing no evidence of breast cancer.

- The friend control may bring their mammogram report or send a release and have

records faxed to the enrolling center.

- Women under the age of 40 should have had a clinical breast examination within 2

years of study entry, showing no need for diagnostic mammography. If a mammogram was required, it should show no evidence of breast cancer.

- The friend control may bring their mammogram / breast exam report or send a release

and have records faxed to the enrolling center.

Locations and Contacts

CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States

North Colorado Medical Center, Greeley, Colorado 80631-5199, United States

McKee Medical Center, Loveland, Colorado 80538, United States

Cancer Centers of Central Florida, PA, Leesburg, Florida 34788, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida 33612-9497, United States

Northeast Georgia Cancer Care, LLC - Medical Oncology, Athens, Georgia 30607, United States

MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912-4000, United States

Medical College of Georgia Cancer Center, Augusta, Georgia 30912-3500, United States

Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois 62002, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois 62864, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana 71130-3932, United States

CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States

William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan 48073, United States

William Beaumont Hospital - Troy Campus, Troy, Michigan 48085, United States

MeritCare Bemidji, Bemidji, Minnesota 56601, United States

Saint Francis Medical Center, Cape Girardeau, Missouri 63703, United States

Southeast Cancer Center, Cape Girardeau, Missouri 63701, United States

David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri 63141, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65804, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri 65807, United States

St. John's Regional Health Center, Springfield, Missouri 65804-2263, United States

CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri 63141, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

MBCCOP - Our Lady of Mercy Comprehensive Cancer Center, Bronx, New York 10466, United States

Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York 10466, United States

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States

Rutherford Internal Medicine Associates, PA, Forest City, North Carolina 28043, United States

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States

Southeastern Medical Oncology Center - Goldsboro, Goldsboro, North Carolina 27534, United States

Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina 27403-1198, United States

Pardee Memorial Hospital, Hendersonville, North Carolina 28791, United States

Iredell Memorial Hospital, Statesville, North Carolina 28687-1828, United States

Southeastern Medical Oncology Center - Wilson, Wilson, North Carolina 27893, United States

Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem, North Carolina 27103, United States

CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States

Roger Maris Cancer Center at MeritCare Hospital, Fargo, North Dakota 58122, United States

AnMed Cancer Center, Anderson, South Carolina 29621, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Scott and White Cancer Institute, Temple, Texas 76508, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2006
Last updated: July 7, 2015

Page last updated: August 23, 2015

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